RALEIGH – The US Food and Drug Administration is saying that the status of warnings about the female sexual dysfunction drug Addyi from Raleigh-based Sprout Pharmaceuticals has not changed contrary to what the company announced last week. Sprout, however, says it is working with the FDA to resolve the matter and has issued a timeline of the back-and-forth with the FDA that it says supports the company’s view.
“The story is definitely getting misreported,” Sprout CEO Cindy Eckert tells WRAL TechWire. “We remain very excited about where we’re headed with Addyi.”
The FDA also said the “Risk Evaluation and Mitigation Strategy for the drug also known as the “female Viagra” has not changed.
The FDA reached out to WRAL TechWire via email following the publication of a story last week in which Sprout said the FDA had made changes regarding use of alcohol with Addyi.
“I wanted to let you know that at this time, the FDA has not revised its warnings about the use of alcohol with Addyi nor has it changed the drug’s Risk Evaluation and Mitigation Strategy (REMS),” Amanda Turney, an FDA press officer, wrote in an email.
Cindy Eckert (Sprout photo)
Sprout responded with a timeline of events regarding Addyi’s labeling and mitigation strategy.
The “appeal process concluded on August 18th with a final decision from the Office of New Drugs at FDA stating their agreement on these two points” regarding restrictions.
However, the issues rose again following the Sprout press release.
“On September 6th, FDA informed Sprout that it objected to our press release and asked that we take the release down. In an effort to be cooperative, Sprout took its release down early on September 7th,” Sprout says.
“Starting September 10th, FDA began alerting media outlets that ‘at this time’ FDA has not made these changes. Sprout issued this timeline of events for absolute clarity.”
Sprout added that the company “look[s] forward to working with the FDA through this implementation phase and are hopeful that FDA will quickly initiate discussions with the company about its submissions and implementation of decisions already reached in the best interest of doctors and patients to avoid unnecessary confusion.”
Sprout and the FDA have been wrangling about restrictions regarding Addyi for months.
Sprout Pharmaceuticals
The timeline from Sprout
The timeline as released by Addyi notes the following events that led to last week’s press announcement.
- April 11, 2019: FDA Order and Press Release
On April 11th, the FDA ordered important labeling changes for Addyi® (flibanserin) instructing Sprout as well as informing women and their healthcare providers as follows: “Based on the results of post marketing studies, the FDA has determined that changes must be made to Addyi’s labeling to clarify that there is still a concern about consuming alcohol close in time to taking Addyi but that it does not have to be avoided completely. Specifically, the boxed warning, contraindication, warnings and precautions, and adverse reactions sections of labeling are being updated to reflect that women should discontinue drinking alcohol at least two hours before taking Addyi at bedtime or to skip the Addyi dose that evening. Women should not consume alcohol at least until the morning after taking Addyi at bedtime.”
- April 11, 2019 – August 18, 2019: The FDA Appeal Process
On April 11th, the same day that the FDA issued its public statements, Sprout initiated the FDA appeal process to also get agreement for removal of the alcohol contraindication, or ban, and the restrictive elements of the REMS (known as ETASU) such as having women sign an attestation saying they will abstain from alcohol. That appeal process concluded on August 18th with a final decision from the Office of New Drugs at FDA stating their agreement on these two points.
Specifically, the Director of FDA’s Office of New Drugs stated, “My assessment is that the new information narrows the risk of the flibanserin-alcohol interaction and that a [boxed warning] and a verifiably comprehensible medication guide should provide appropriate management of the risk. Based upon this, a REMS that includes a medication guide, but not ETASU, is appropriate to ensure that the benefits outweigh the risks. The company should submit a request to modify the REMS, as described above.” Regarding the Contraindication, the Director stated, “The labeling should, therefore, be revised so that the [contraindication] is limited to women on moderate or strong CYP3A4 inhibitors or who have hepatic impairment, populations for whom the benefit of treatment do not outweigh its risks. The Company can submit a proposed revised labeling that removes the contraindication for use of alcohol with flibanserin.”
- August 29, 2019:
Sprout complied with the FDA’s request and submitted all required paperwork to modify the labeling and REMS within 11 days. Sprout submitted a CBE-0 supplement implementing the FDA’s April 11 language and removing the contraindication and reference to ETASU from the labeling in accordance with the appeal decision. Sprout also submitted a REMS modification supplement to replace the ETASU with a medication guide.
- September 4, 2019 – Present
Sprout issued a press release announcing these events the week following their finalized submission and two weeks after receipt of the Office of New Drugs final decision letter. The new labeling language that Sprout announced is consistent with the language FDA laid out on April 11th and included the update from FDA’s appeal decision as it relates to removing the alcohol contraindication and language about the ETASU.”
The initial news
Last week, Sprout said that instead of a ban or “contraidication” on alcohol use, Sprout said that the FDA said patients should not consume alcohol two hours before using the drug.
The FDA also no longer requires that physicians that healthcare providers and pharmacies no longer must be certified through the FDA’s Risk Evaluation and Mitigation Strategy known as REMS to prescribe or dispense Addyi, Sprout said.
“It’s a new day for women,” Eckert said in the announcement. “As the first-and-only FDA approved non-hormonal treatment for HSDD [Hypoactive sexual desire disorder] in premenopausal women, Addyi offers a critical treatment option to help those struggling with this condition.
“No longer are women stuck choosing between treatment and a glass of wine. Outside of the day we broke through with the first approval in this category, this represents the biggest shift toward greater access for women in need.”
Eckert had been embroiled in lengthy negotiations with the FDA about the previous limits on Addyi.
“I spent $10 million just to do additional scientific work on Addyi and alcohol interaction,” Eckert told Fortune magaizne in an interview published a week ago.
“On the basis of those findings, the FDA has ruled they will lift the alcohol contraindication.”
Sprout recently disclosed $15.9 million in new venture capital to finance expected growth of the company.
Fortune reported that Addyi had raised $20 million in all.
